Preparation and Characterization of a Suite of Ephedra-Containing Standard Reference Materials

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Abstract:

The National Institute of Standards and Technology, the U.S. Food and Drug Administration, Center for Drug Evaluation and Research and Center for Food Safety and Applied Nutrition, and the National Institutes of Health, Office of Dietary Supplements, are collaborating to produce a series of Standard Reference Materials (SRMs) for dietary supplements. A suite of ephedra materials is the first in the series, and this paper describes the acquisition, preparation, and value assignment of these materials: SRMs 3240 Ephedra sinica Stapf Aerial Parts, 3241 E. sinica Stapf Native Extract, 3242 E. sinica Stapf Commercial Extract, 3243 Ephedra-Containing Solid Oral Dosage Form, and 3244 Ephedra-Containing Protein Powder. Values are assigned for ephedrine alkaloids and toxic elements in all 5 materials. Values are assigned for other analytes (e.g., caffeine, nutrient elements, proximates, etc.) in some of the materials, as appropriate. Materials in this suite of SRMs are intended for use as primary control materials when values are assigned to in-house (secondary) control materials and for validation of analytical methods for the measurement of alkaloids, toxic elements, and, in the case of SRM 3244, nutrients in similar materials.

Document Type: Research Article

Affiliations: 1: National Institute of Standards and Technology, Analytical Chemistry Division, Gaithersburg, MD 20899-8390. 2: U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, College Park, MD 20740-3835. 3: National Institutes of Health, Office of Dietary Supplements, Bethesda, MD 20892. 4: National Institute of Standards and Technology, Analytical Chemistry Division, Gaithersburg, MD 20899-8392. 5: National Research Council Canada, Ottawa, Ontario, Canada K1A 0R9. 6: Food Products Association, Washington, DC 20005. 7: National Institute of Standards and Technology, Analytical Chemistry Division, Gaithersburg, MD 20899-8392: Permanent address: National Metrology Institute of Japan, AIST, Tsukuba, Japan. 8: U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993. 9: National Institute of Standards and Technology, Analytical Chemistry Division, Gaithersburg, MD 20899-8395. 10: ChromaDex, Inc., Clearwater, FL 33760. 11: National Institute of Standards and Technology, Analytical Chemistry Division, Gaithersburg, MD 20899-8391. 12: ChromaDex, Inc., Clearwater, FL 33760: Present address: Tampa Bay Analytical Research, Inc., Safety Harbor, FL 34695-0931. 13: National Institute of Standards and Technology, Statistical Engineering Division, Gaithersburg, MD 20899-8980.

Publication date: November 1, 2006

More about this publication?
  • The Journal of AOAC INTERNATIONAL publishes refereed papers and reviews in the fields of chemical, biological and toxicological analytical chemistry for the purpose of showcasing the most precise, accurate and sensitive methods for analysis of foods, food additives, supplements and contaminants, cosmetics, drugs, toxins, hazardous substances, pesticides, feeds, fertilizers and the environment available at that point in time. The scope of the Journal includes unpublished original research describing new analytical methods, techniques and applications; improved approaches to sampling, both in the field and the laboratory; better methods of preparing samples for analysis; collaborative studies substantiating the performance of a given method; statistical techniques for evaluating data. The Journal will also publish other articles of general interest to its audience, e.g., technical communications; cautionary notes; comments on techniques, apparatus, and reagents.
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